The world population is expected to reach 9.8 billion by 2050. If the current rate of food production remains the same, the demand for food will likely outpace it. Fortunately, this concern has driven efforts to find a solution to this scenario through plant-related inventions.

Plant breeding techniques have been applied in order to produce crops with improved agronomic features, resistance to diseases, plagues and pests, or tolerance to heat and drought. Thus, the paramount importance of plant-related inventions is undeniable.

According to the TRIPS Agreement, patents shall be available for any inventions, whether products or processes, in all fields of technology. However, the same treaty says that essentially biological processes for the production of plants as well as plant varieties can be excluded from patentability.

In this context, it is widely agreed that transgenic plant inventions are clearly patentable as they are not obtained by essentially biological processes, but rather by applying recombinant DNA techniques.

In accordance with the drafting of article 27.3(b) from TRIPS, the products of such essentially biological processes are not necessarily non-eligible for protection.

Decisions

In this regard, in decisions G 2/12 and G 2/13 from the European Patent Office’s (EPO’s) Enlarged Board of Appeal in 2015, the board ruled that the exclusion of essentially biological processes for the production of plants shall be construed narrowly. Furthermore, the board found that patent claims directed to plants or plant products are patentable even if produced through essentially biological methods, provided that the invention is not confined to a particular plant variety.

Later, in 2016, the European Commission issued a notice stating that the exclusion to patentability should be extended to the products obtained by essentially biological processes. While the notice was not legally binding on the EPO, the prosecution of all affected cases was stayed until further clarification. Finally, on July 1, 2017, the EPO decided to amend the EPC Regulation in order to follow the Commission’s recommendation.

“Even where plants were obtained through the assistance of markers or other molecular techniques (a so-called technical step), this is no longer persuasive to Mexican examiners.”

In the case of Mexico, the Industrial Property Law (IP Law) states that essentially biological processes for the production, reproduction and propagation of plants and animals as well as plant varieties are not eligible for protection, in line with TRIPS provisions.

A narrow interpretation of the above exclusions can be shown by the number of patents issued in Mexico to non-transgenic plant-related inventions. Specifically, around 278 patents have been granted by the Mexican Institute of Industrial Property (IMPI) since 2011.

It is noteworthy that the interest in the protection of such inventions has been growing in recent years, from one patent application filed in 1995 to the 55 applications filed with the IMPI in 2013 relating to non-transgenic plant-related inventions.

Some examples of non-transgenic plant-related inventions granted by the IMPI are plants defined by alleles, specific QTLs, or characterised by a genetic locus linked to molecular markers that are related to desirable agronomical traits.

Changing emphasis

This patentability criterion suddenly changed as of October 2017, as plants obtained by essentially biological processes have been increasingly objected to by Mexican examiners since then on the grounds of allegedly referring to plant varieties.

Even where plants were obtained through the assistance of markers or other molecular techniques (a so-called technical step), this is no longer persuasive to Mexican examiners.

Notwithstanding the above, according to TRIPS and the Mexican IP Law, the methods used to obtain a plant, including crossing, backcrossing and selection, are irrelevant in determining whether a plant is eligible for protection, provided that the invention is not related to a plant variety, as no legal provision explicitly excludes the products of essentially biological processes from patentability.

In addition, there are no amendments in the Mexican IP Law or bills to be approved or discussed by Mexican legislators in this regard. Instead, it seems that this shift in the patentability criteria was unilaterally applied by the IMPI after the recent amendments to the EPC Regulations. Moreover, this shift has been only noticed through the day-to-day prosecution of patent applications, without having received any official notice or warning.

What is the reason for such a shift? Examination of patent applications is expensive and complex, inasmuch as it involves investing human, material and financial resources in the analysis of the technologies for which applicants seek protection.

In order to address this issue, the IMPI has traditionally adopted the solution of relying on the work done by other patent offices. Under this practice, the IMPI has been able to optimise resources by deferring to the examinations carried out in other jurisdictions such as Europe, the US and Japan.

Using the work done by other patent offices can contribute to expediting the examination of patent applications without further expenditure of resources, even though it is questionable to adopt examination criteria from other jurisdictions, which may address different socio-economic conditions, without carefully considering the needs of the particular country and the corresponding impact in the national patent and innovation system.

On one hand, the unilateral adoption of the EPO’s criteria by the IMPI does not seem to take into account the specific conditions of Mexico and Mexican inventors, since no major public discussion was held in order to assess the relevance of said measure (unlike in Europe).

On the other hand, the shift has no legal basis.

As discussed, in this regard, the IP Law states that only essentially biological processes for the production, reproduction and propagation of plants are excluded from patentability.

Furthermore, according to the same regulation, an invention can fall into one or more of four categories: product, process, apparatus or medium. Thus, if the exclusion is directed to processes, which clearly belong to a category of protection different from products, it is not reasonable to broadly construe the exclusion to the plants obtained from essentially biological processes, as such construction would be both false and undue in view of what is clearly and explicitly stated in the Mexican IP Law.

New criteria

A summary of the new criteria adopted by the IMPI is shown below:

Products obtained by essentially biological process are no longer patent-eligible, regardless of the claim language, format, or drafting used (even if material deposited under the Budapest Treaty is claimed).

Essentially biological processes for production, reproduction and propagation of plants are deemed as procedures involving the crossing of the whole genomes of two plants and selecting a plant having the desired traits.

Adding a technical step to the essentially biological processes, e.g., by using molecular markers, does not render the product eligible for protection.

Asexual propagation and hybridisation methods and products thereof are not patentable either. The patentability of methods using other plant breeding techniques would be assessed on a case-by-case basis.

In spite of the above, plants produced by human-induced mutagenesis, genetic engineering, and in vitro technologies (even if they do not involve recombinant DNA technology), are still eligible for protection.

As this shift in the examination criteria has not been supported with an amendment to the applicable legal framework, some important questions remain without a clear and final answer.

According to the IMPI, granted patents covering products of biologically essential processes shall not be invalidated ex officio. However, if a third party with a legal interest filed a nullity action with the IMPI against any such patents, what would be the outcome? Would the granted patent be reassessed with the prior criteria or the new ones? What is the risk of such patents of being easily invalidated? Undoubtedly, this shift in the examination criteria creates legal uncertainty for patent owners and other stakeholders.

On the other hand, about 100 pending patent applications related to products of biologically essential processes were filed in Mexico before the shift, and they will probably be rejected in the coming months or years. If an applicant filed an appeal against any of these rejections, what would be the opinion of the Mexican courts? Could the shift in the examination criteria be turned down? Or would the rejection decision be upheld?

The only way to find out is to bring this matter to light and to its very end. In our opinion, the shift could be reversed with an appropriate legal strategy. So, what innovative company is ready for the challenge?

Daniel Eduardo López is a consultant at Clarke, Modet & Co., where he provides expert advice to national and international clients on IP matters and is responsible for the substantive examination procedures of patent prosecution in Mexico and Latin America. He can be contacted at: delopez@clarkemodet.com.mx

Esteban Rodríguez is a consultant at Clarke, Modet & Co.. His practice is focused on advising national and international clients on IP matters, mainly related to chemistry, biotech and pharma projects. Esteban can be contacted at: erodrigueza@clarkemodet.com.mx